SUPPLY CHAIN ARTICLES
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![Leprechaun Man Dancing-GettyImages-538148163]( "ARW's ATMP Manufacturing Must-Reads (ST. PATRICK'S DAY EDITION!)")
ARW's ATMP Manufacturing Must-Reads (ST. PATRICK'S DAY EDITION!)Day-in and day-out, I write, read, listen to, and watch as much content as I can about CGT and RNA therapy manufacturing, in particular, and/or other ATMP industry-related topics that you should at least be aware of in the manufacturing facility. Once a month, I compile the articles and industry updates I think are most worthy of your time into an unconventional roundup article.
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![coronavirus covid-GettyImages-1220020527]( "FDA Sets Recommendations For Predicting Dangerous Nitrosamine Impurities")
FDA Sets Recommendations For Predicting Dangerous Nitrosamine ImpuritiesThe FDA recently published a final guidance that sets a recommended framework for predicting the potential of nitrosamine drug substance-related impurities.
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![Business Unity-GettyImages-1253212054]( "The RNA Therapeutics Supply Chain: A Platform of Relationships")
The RNA Therapeutics Supply Chain: A Platform of RelationshipsConversations digging into RNA-specific sourcing considerations have been few and far between. Enter Sanofi's Greg Troiano. Together, we delved into the nuances, challenges, and opportunities for growth that currently exist within the mRNA drug substance and drug product (i.e., mRNA-LNP) raw material sourcing worlds.
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![Engraver-wood-working-GettyImages-505274864]( "Defining The RNA Therapeutics Industry In 2023")
Defining The RNA Therapeutics Industry In 2023Four executives outline which industry challenges, strategic considerations, and opportunities should be top of mind as RNA therapeutics companies establish their to-do lists for 2023.
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![Future business concept-GettyImages-1390149628]( "5 Critical Regulatory Topics To Watch In The Oligo Sector")
5 Critical Regulatory Topics To Watch In The Oligo SectorThough our guidances have helped us achieve upwards of 20 commercially approved oligo products, as I listened to GSK’s director of CMC policy and advocacy, Katie Duncan, present at TIDES, it struck me just how far we have yet to come. Here, I single out a few of the biggest topics of regulatory discussion shaping the oligo therapeutics market.
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![Man working in vegetable garden-GettyImages-1327986655]( "Cultivating A Thriving mRNA Ecosystem: Key Initiatives & Future Directions")
Cultivating A Thriving mRNA Ecosystem: Key Initiatives & Future DirectionsOverall, I felt that the following initiatives/talking points were demonstrative of the types of creativity and symbiosis that we will need much more of in the near and long-term to foster a healthy and fruitful RNA ecosystem.
SUPPLY CHAIN VIDEOS
Camp4’s Satya Kuchimanchi highlights where he has seen the most growth in the oligo supply chain over the past few years, as well as which industry trends have been driving these shifts.
Achieving cost-effective manufacturing while maintaining high quality standards today is one of the biggest challenges facing companies outsourcing mRNA/RNA development. In turn, panelists Qian Ruan, Andy Geall, and Alex Aust reflect on how and where they’ve seen the costs of mRNA-LNP manufacturing evolving/fluctuating in recent years.
Here, Ethris’ Christan Dohmen and Tune Therapeutics’ Stu Sundseth share their take on the most meaningful strategies for reducing dsRNA production. But this discussion also probes a deeper question: Is dsRNA still the most relevant impurity the industry should be chasing, or should focus shift to other contaminants?
The oligo manufacturing paradigm is facing several different evolutions whether it be the transition to liquid-phase or hybrid synthesis. In this Advancing RNA Live clip, Camp4’s Satya Kuchimanchi explores how these manufacturing advancements are impacting our supply chain needs.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-1284041821 asian vaccine]( "Revolutionizing Patient-Centric Supply Chains To Improve Vaccine Access")
Transparent collaboration and innovation are essential to establishing an infrastructure that supports more agile business models and empowers widespread vaccine access.
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![GettyImages-1333406903-liquid-nitrogen-cryopreservation-cold-chain]( "Accelerate Efficiency By Decoupling Collection From Manufacturing")
Cryopreservation eliminates rigid timelines by decoupling collection from production, providing the flexibility needed to optimize facility use and stabilize advanced therapy supply chains.
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![Advancing RNA_Primrose Scientific Poster]( "Advancing mRNA Therapeutics With High Performance RNA Polymerases")
Learn how optimized RNA polymerases enhance mRNA therapeutic quality and transcript integrity by increasing yield and capping efficiency while reducing double-stranded RNA impurities.
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![Integrating Genetic Medicine Into Clinical Care]( "Optimization Of Transient Transfection Of MSCs With Plasmid DNA Or mRNA")
Read through the results of our efforts to produce an optimal protocol for the transient transfection of hMSCs with pDNA or mRNA using non-viral means.
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![GettyImages-155372946-cold-chain-cryopreservation-logistics]( "Supercharge Your Supply Chain: Harness AI To Gain Competitive Advantage")
The success of CGTs hinges upon adherence to specific logistics protocols. Learn how the integration of AI in the pharma supply chain is poised to enhance visibility, efficiency, and compliance.
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![Cryoport]( "Accelerate Your Trials With An End‑To‑End Supply Chain Model")
An end-to-end supply chain model helps clinical trials move faster while maintaining visibility, control, and risk management across complex, temperature‑sensitive, and global operations.
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![deep freezing cryopreservation GettyImages-952307842]( "Pioneering The Future Of Pharmaceutical Supply Chains")
Drive the efficiency and resiliency of supply chains by integrating automation, AI, and effective communication, ensuring the successful distribution of lifesaving medicinal products.
